Substance Use Disorders (SUDs)ROOTSNCT07746401
Recovery Opportunities Through Ongoing Treatment Sustainment
A study testing Youth Substance Use Unit in people with Substance Use Disorders (SUDs), run by University of Maryland, College Park.
Trial summary
Adolescents in rural communities face limited access to effective substance use services, increasing their risk for opioid and other substance use disorders. This project will use an adaptive, iterative implementation approach to improve the integration of external substance use service providers into rural school… Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Substance Use Disorders (SUDs)
- What is being tested?
- Youth Substance Use Unit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Are enrolled in one of the participating schools
- Are referred or independently access YSU services;
- Are above age of 13
Who cannot join
- Demonstrating active, unstable or untreated psychiatric symptoms, including mania and/or psychosis that would interfere with study participation
- Inability to understand the study and provide informed consent in English
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Recovery Opportunities Through Ongoing Treatment Sustainment (ROOTS): A Dynamic Approach to Integrate and Sustain Adolescent Substance Use Services in Rural Schools
Adolescents in rural communities face limited access to effective substance use services, increasing their risk for opioid and other substance use disorders. This project will use an adaptive, iterative implementation approach to improve the integration of external substance use service providers into rural school settings. Findings will inform strategies to integrate and scale adolescent substance use services in schools. Support for this trial is provided by the HEAL Initiative (https://heal.nih.gov/).
Read the detailed description
Rural adolescents are more likely than their peers in urban areas to engage in high-risk substance use, including opioid misuse. Rural adolescents also face challenges accessing behavioral care because of limited clinics and providers in rural settings, including substance use care providers. External specialists may fill a critical gap in augmenting existing school-based services; however, challenges in cross-system coordination contribute to poor reach and retention in care. These challenges are particularly urgent given the need to treat opioid use disorder (OUD) and prevent escalation to OUD among high-risk adolescents with other substance use disorder (SUD) or behavioral health challenges. Research is needed to identify implementation strategies that support cross-system coordination without overburdening existing school staff. The proposed K23 will examine the implementation and effectiveness of an innovative community partnership-the Youth Substance Use Unit (YSU), a collaboration between schools and local substance use service providers that delivers services to adolescents with substance use problems at high schools on the rural Eastern Shore of Maryland. Guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, the study has three aims: (1) identify determinants and opportunities to improve implementation of the YSU by conducting semi-structured interviews with constituents (e.g., school personnel, peer recovery specialists); (2) develop and adapt initial implementation strategies to improve reach and implementation of the YSU into rural schools based on constituent feedback using Implementation Mapping, a participatory approach to co-develop and specify implementation strategies; and (3) test the effectiveness and implementation of the YSU in Type 2 hybrid effectiveness-implementation trial using an adaptive-iterative design. Support for this trial is provided by the HEAL Initiative (https://heal.nih.gov/).
- Conditions
- Substance Use Disorders (SUDs)
- Being tested
- Youth Substance Use Unit
- Keywords
- Substance-Related Disorders, School Behavioral Health, Rural Behavioral Health
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Youth Substance Use UnitBehavioural
The YSU provides adolescents access to several evidence-based interventions, including access to an on-site substance use counselor trained in evidence-based practices for adolescent SUD, peer recovery specialists, and, if indicated, virtual access to an OUD treatment provider and/or clinical psychologist for more acute and co-occurring disorder treatment.
| Study group | Role | What they receive |
|---|---|---|
| Youth Substance Use Unit | Experimental | The YSU provides adolescents access to several evidence-based interventions, including access to an on-site substance use counselor trained in evidence-based practices for adolescent SUD, peer recovery specialists, and, if indicated, virtual access to an OUD treatment provider and/or clinical psychologist for more acute and co-occurring disorder treatment. Receives: Behavioral: Youth Substance Use Unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach and Engagement
Reach and Engagement will be tracked through service logs, including the number of students referred, completed referrals, and retention in care.
Measured: From enrollment to 90-day follow-up
90-day Substance Use Self Report
The timeline followback will be used to assess self-reported substance use frequency
Measured: Measured from baseline to 90-day follow-up
90-Day Substance Use Urinalysis
Substance use will be assessed using urinalysis.
Measured: Measured from baseline to 90-day follow-up.
Opioid-related knowledge and likelihood to engage in misuse behaviors
Opioid-related knowledge and likelihood to engage in misuse behaviors will be assessed with the Adolescent Opioid Safety and Learning scale. The Adolescent Opioid Safety and Learning Scale is a 16-item instrument comprising four separately scored subscales: Opioid Learning Interest (5 items; summed score range 5-25, with higher scores indicating greater interest in learning about opioid safety), Opioid Misuse Behavior Recognition (4 yes/no items; summed score range 0-4, with higher scores indicating better recognition of opioid misuse), Likelihood to Misuse Opioids (4 items; summed score range 4-20, with higher scores indicating a greater likelihood of opioid misuse and therefore a worse outcome), and Opioid Harm (3 items; summed score range 3-15, with higher scores indicating greater perceived harm from opioid misuse). The four subscales will be analyzed separately.
Measured: Assessed from baseline to 90-day follow-up
Secondary outcomes (3)
Motivation for substance use and problems associated
Motivation for substance use and problems associated will be measured with the Short Inventory of Problems
Measured: Assessed between the baseline assessment and 90-day follow-up
Depressive Symptoms
Depressive symptoms will be assessed with the Patient Health Questionnaire-9. The Patient Health Questionnaire-9 is a 9-item self-report measure of depressive symptom severity during the preceding two weeks. Each item is scored from 0 ("not at all") to 3 ("nearly every day"). Item scores are summed to produce a total score ranging from 0 to 27. Higher scores indicate greater depressive symptom severity and therefore a worse outcome.
Measured: Assessed between the baseline assessment and 90-day follow-up
Anxiety Symptoms
Anxiety symptoms will be measured with the Generalized Anxiety Disorder 7-item scale (GAD-7). The Generalized Anxiety Disorder is a 7-item self-report measure of anxiety symptom severity during the preceding two weeks. Each item is scored from 0 ("not at all") to 3 ("nearly every day"). Item scores are summed to produce a total score ranging from 0 to 21. Higher scores indicate greater anxiety symptom severity and therefore a worse outcome.
Measured: Assessed from baseline to 90-day follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use Disorders (SUDs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study builds on an innovative community partnership, the Youth Substance Use Unit (YSU), which serves adolescents with substance use problems at high schools on the Eastern Shore of Maryland. The YSU provides adolescents access to several evidence-based interventions, including access to an on-site substance use counselor trained in evidence-based practices for adolescent SUD, peer recovery specialists, and, if indicated, virtual access to an OUD treatment provider and/or clinical psychologist for more acute and co-occurring disorder treatment.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Noah S Triplett, PhD, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746401
- Sponsor's protocol ID
- 2342
- Other IDs
- 1K23DA065849-01
- Acronym
- ROOTS
- Status last verified
- Sep 2026
- First submitted
- 29 Jul 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified quantitative datasets (adolescent clinical outcomes, implementation metrics), de-identified transcripts, coded qualitative outputs (e.g., theme matrices), and strategy adaptation documentation (FRAME-IS) will be preserved and shared to enable replication, secondary analysis, and transparency in implementation research. Data will be submitted to the National Addiction and Health Data Archive Program in alignment with the HEAL Data Sharing Policy.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Opportunities Through Ongoing Treatment Sustainment (ROOTS): A Dynamic Approach to Integrate and Sustain Adolescent Substance Use Services in Rural Schools
- ClinicalTrials.gov ID
- NCT07746401
- Acronym / sponsor ID
- ROOTS / 2342
- Conditions
- Substance Use Disorders (SUDs)
- Keywords
- Substance-Related Disorders, School Behavioral Health, Rural Behavioral Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adolescents in rural communities face limited access to effective substance use services, increasing their risk for opioid and other substance use disorders. This project will use an adaptive, iterative implementation approach to improve the integration of external substance use service providers into rural school settings. Findings will inform strategies to integrate and scale adolescent substance use services in schools. Support for this trial is provided by the HEAL Initiative (https://heal.nih.gov/).
Detailed description
Rural adolescents are more likely than their peers in urban areas to engage in high-risk substance use, including opioid misuse. Rural adolescents also face challenges accessing behavioral care because of limited clinics and providers in rural settings, including substance use care providers. External specialists may fill a critical gap in augmenting existing school-based services; however, challenges in cross-system coordination contribute to poor reach and retention in care. These challenges are particularly urgent given the need to treat opioid use disorder (OUD) and prevent escalation to OUD among high-risk adolescents with other substance use disorder (SUD) or behavioral health challenges. Research is needed to identify implementation strategies that support cross-system coordination without overburdening existing school staff. The proposed K23 will examine the implementation and effectiveness of an innovative community partnership-the Youth Substance Use Unit (YSU), a collaboration between schools and local substance use service providers that delivers services to adolescents with substance use problems at high schools on the rural Eastern Shore of Maryland. Guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, the study has three aims: (1) identify determinants and opportunities to improve implementation of the YSU by conducting semi-structured interviews with constituents (e.g., school personnel, peer recovery specialists); (2) develop and adapt initial implementation strategies to improve reach and implementation of the YSU into rural schools based on constituent feedback using Implementation Mapping, a participatory approach to co-develop and specify implementation strategies; and (3) test the effectiveness and implementation of the YSU in Type 2 hybrid effectiveness-implementation trial using an adaptive-iterative design. Support for this trial is provided by the HEAL Initiative (https://heal.nih.gov/).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study builds on an innovative community partnership, the Youth Substance Use Unit (YSU), which serves adolescents with substance use problems at high schools on the Eastern Shore of Maryland. The YSU provides adolescents access to several evidence-based interventions, including access to an on-site substance use counselor trained in evidence-based practices for adolescent SUD, peer recovery specialists, and, if indicated, virtual access to an OUD treatment provider and/or clinical psychologist for more acute and co-occurring disorder treatment.
| Arm | Type | Receives |
|---|---|---|
| Youth Substance Use Unit | Experimental | Behavioral: Youth Substance Use UnitThe YSU provides adolescents access to several evidence-based interventions, including access to an on-site substance use counselor trained in evidence-based practices for adolescent SUD, peer recovery specialists, and, if indicated, virtual access to an OUD treatment provider and/or clinical psychologist for more acute and co-occurring disorder treatment. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Are enrolled in one of the participating schools
- Are referred or independently access YSU services;
- Are above age of 13
Key exclusion criteria (2 listed)
- Demonstrating active, unstable or untreated psychiatric symptoms, including mania and/or psychosis that would interfere with study participation
- Inability to understand the study and provide informed consent in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Youth Substance Use UnitThe YSU provides adolescents access to several evidence-based interventions, including access to an on-site substance use counselor trained in evidence-based practices for adolescent SUD, peer recovery specialists, and, if indicated, virtual access to an OUD treatment provider and/or clinical psychologist for more acute and co-occurring disorder treatment. | Behavioural | Youth Substance Use Unit |
Primary outcome
Reach and Engagement
Time frame: From enrollment to 90-day follow-up
Reach and Engagement will be tracked through service logs, including the number of students referred, completed referrals, and retention in care.
90-day Substance Use Self Report
Time frame: Measured from baseline to 90-day follow-up
The timeline followback will be used to assess self-reported substance use frequency
90-Day Substance Use Urinalysis
Time frame: Measured from baseline to 90-day follow-up.
Substance use will be assessed using urinalysis.
Opioid-related knowledge and likelihood to engage in misuse behaviors
Time frame: Assessed from baseline to 90-day follow-up
Opioid-related knowledge and likelihood to engage in misuse behaviors will be assessed with the Adolescent Opioid Safety and Learning scale. The Adolescent Opioid Safety and Learning Scale is a 16-item instrument comprising four separately scored subscales: Opioid Learning Interest (5 items; summed score range 5-25, with higher scores indicating greater interest in learning about opioid safety), Opioid Misuse Behavior Recognition (4 yes/no items; summed score range 0-4, with higher scores indicating better recognition of opioid misuse), Likelihood to Misuse Opioids (4 items; summed score range 4-20, with higher scores indicating a greater likelihood of opioid misuse and therefore a worse outcome), and Opioid Harm (3 items; summed score range 3-15, with higher scores indicating greater perceived harm from opioid misuse). The four subscales will be analyzed separately.
3 secondary outcomes
Motivation for substance use and problems associated
Time frame: Assessed between the baseline assessment and 90-day follow-up
Depressive Symptoms
Time frame: Assessed between the baseline assessment and 90-day follow-up
Anxiety Symptoms
Time frame: Assessed from baseline to 90-day follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified quantitative datasets (adolescent clinical outcomes, implementation metrics), de-identified transcripts, coded qualitative outputs (e.g., theme matrices), and strategy adaptation documentation (FRAME-IS) will be preserved and shared to enable replication, secondary analysis, and transparency in implementation research. Data will be submitted to the National Addiction and Health Data Archive Program in alignment with the HEAL Data Sharing Policy.
Related trials for Substance Use Disorders (SUDs)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers
Not yet recruiting
Enhancing Delivery of Parenting Support Within a Peer Recovery Support Service Model
Substance Use Disorders (SUDs)
Not yet recruiting
Supportive Treatment With Enhanced Post-Incarceration Services
Substance Use Disorders (SUDs)
Active, not recruiting
Effectiveness of Depression and Substance Use Module for Patients With Co-occurring Disorders
Depression, Substance Use Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Noah S Triplett, PhD principal investigator
University of Maryland, College Park
Questions about this trial
What is this clinical trial studying?
A study testing Youth Substance Use Unit in people with Substance Use Disorders (SUDs), run by University of Maryland, College Park.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noah S Triplett, PhD ((301) 405-5862, ntrip7@umd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach and Engagement (time frame: From enrollment to 90-day follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.